Non-opioid analgesic shows efficacy in several animal pain models, including diabetic and chemotherapy-induced neuropathic pain Compelling safety and pharmacokinetic profiles in animals support IND-enabling studies CHATHAM, N.J., Dec. 16, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated commercial biotechnology company, today announced licensing exclusive worldwide rights to TNX-4900 (formerly known as PW507), a highly selective small ...

Ms. Ishak brings more than 25 years of corporate legal and strategic leadership experience in the life sciences industryCHATHAM, N.J., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated commercial-stage biotechnology company today announced the appointment of Irina Ishak as General Counsel, effective December 8, 2025. Ms. Ishak will lead Tonix’s legal, corporate governance, and compliance functions. “Irina is a highly accomplis ...

Summary of Tonix Pharmaceuticals Holding Conference Call Company Overview - **Company**: Tonix Pharmaceuticals Holding (NasdaqCM: TNXP) - **Focus**: CNS (Central Nervous System), immunology, infectious disease, and rare disease - **Recent Development**: FDA approval of Tonmya for fibromyalgia on August 15, 2025, with a commercial launch expected by the end of November 2025 [2][3] Key Points Product Launch and Financials - **Product**: Tonmya, a sublingual tablet containing cyclobenzaprine, designed for chronic dosing in fibromyalgia treatment [3][4] - **Market Size**: Approximately 10 million American adults suffer from fibromyalgia, with only about 3 million diagnosed and treated [10] - **Financial Position**: As of September 2025, the company reported $190 million in cash, no debt, and a cash runway extending into Q1 2027, fully funding the product launch [3] Market Opportunity - **Unmet Need**: Current FDA-approved treatments for fibromyalgia have high dissatisfaction rates among patients and prescribers, leading to off-label use of opiates [5][10] - **Market Dynamics**: Tonmya enters a market with a 100% share of voice and no counter-promotion, with patent exclusivity until 2034 [5] Product Efficacy and Differentiation - **Efficacy**: Clinical trials showed that Tonmya had a 30% responder rate of 47% compared to 35% for placebo in one study, and 46% versus 27% in another [14] - **Tolerability**: Tonmya demonstrated a favorable side effect profile with minimal adverse events, no significant weight gain, and no cognitive dysfunction reported [15][16] Sales and Marketing Strategy - **Sales Force**: A dedicated team of 90 representatives will target 25,000 healthcare providers who prescribe 70% of fibromyalgia medications [12] - **Omnichannel Approach**: The launch strategy includes unbranded promotion and engagement with prescribers through various channels [12] Pipeline Developments - **Ongoing Studies**: Tonix has several programs in development, including: - TNX-102 SL for acute stress disorder and major depressive disorder [18][19] - Anti-CD40 ligand for autoimmune diseases, with a phase two study planned for kidney transplant recipients [21] - TNX-4800 for Lyme disease prevention, ready for phase two trials [24] - Treatment for Prader-Willi syndrome, with a study expected to start in the second half of 2026 [26] Additional Insights - **Chronic Pain Understanding**: Fibromyalgia is characterized by chronic widespread pain, non-restorative sleep, and fatigue, with a significant portion of patients experiencing polypharmacy [6][7] - **Regulatory Challenges**: The company has faced challenges in PTSD studies but has gathered extensive data that may support future product development for acute stress disorder [30][32] Conclusion - **Strategic Positioning**: Tonix Pharmaceuticals is poised for a successful launch of Tonmya, backed by a strong financial position and a diverse pipeline aimed at addressing significant unmet medical needs in chronic pain and other conditions [28]

Group 1 - Tonix Pharmaceuticals presented promising preclinical data for its investigational mpox and smallpox vaccine candidate, TNX-801, at the World Vaccine Congress Europe 2025 [1][2] - The TNX-801 vaccine demonstrated strong immune responses, long-term protection for at least 14 months, and favorable safety across multiple animal models [2] - The company is pursuing a Phase I clinical trial in collaboration with the Kenya Medical Research Institute and is exploring microneedle patch technology for vaccine administration [2] Group 2 - Tonix Pharmaceuticals is currently unprofitable, with analysts not expecting profitability this year [2] - The company focuses on developing therapies and vaccines for central nervous system disorders, immunology, infectious diseases, and rare diseases [2] - Tonix also markets existing products for the treatment of acute migraine headaches, such as Zembrace SymTouch and Tosymra [2]

Core Insights - The RESILIENT trial data demonstrates that TNX-102 SL significantly reduces fibromyalgia pain compared to placebo, confirming previous findings from the RELIEF trial [1][2] - If approved, TNX-102 SL will be the first new drug for fibromyalgia in over 15 years, with a PDUFA target date set for August 15, 2025 [1][2] Company Overview - Tonix Pharmaceuticals Holding Corp. is a clinical-stage biopharmaceutical company focused on developing therapies for pain management and central nervous system disorders [8] - The company has submitted a New Drug Application (NDA) for TNX-102 SL based on two statistically significant Phase 3 studies [2][8] Study Details - The RESILIENT study was a randomized, double-blind, placebo-controlled trial involving 457 adults with fibromyalgia across 33 sites in the U.S. [2][7] - Participants received TNX-102 SL in two dosage phases: 2.8 mg for two weeks followed by 5.6 mg for twelve weeks, with a primary endpoint of pain reduction assessed over fourteen weeks [2][7] Efficacy Results - TNX-102 SL achieved a least-squares mean reduction of 1.8 points on the eleven-point daily pain numeric rating scale, compared to a 1.2-point reduction for placebo, indicating high statistical significance [2][7] - Statistically significant improvements were also noted across all six prespecified key secondary endpoints, including various patient-reported outcomes [2][3] Safety Profile - TNX-102 SL was generally well tolerated, with the most common adverse events being mild and transient, such as oral tingling/numbness and a bitter aftertaste [3] - No serious drug-related adverse events or deaths were reported, highlighting a favorable risk-benefit profile [3] Fibromyalgia Context - Fibromyalgia affects an estimated 6-12 million adults in the U.S., predominantly women, and is characterized by chronic pain, fatigue, and sleep disturbances [4] - Current treatment options are often met with dissatisfaction from both physicians and patients, indicating a significant unmet need in the market [4] Product Information - TNX-102 SL is a patented sublingual formulation of cyclobenzaprine hydrochloride designed for rapid absorption and reduced side effects [5][6] - The drug is also being explored for other indications, including acute stress reaction, Long COVID, and alcohol use disorder [5][8]

Core Insights - Tonix Pharmaceuticals announced that its vaccine candidate TNX-801 provides durable protection against monkeypox after a single dose [1][3] - The vaccine is well tolerated in immunocompromised animals, showing no evidence of spreading to blood or tissues even at high doses [2][3] - TNX-801 is designed to generate both humoral and cellular immunity and serves as a platform for delivering multiple protective antigens against various viral pathogens [3][4] Company Overview - Tonix Pharmaceuticals is a fully-integrated biopharmaceutical company focused on developing therapies for pain management and vaccines for public health challenges [6] - The company has a diverse development portfolio, including TNX-102 SL for fibromyalgia, which has a PDUFA goal date of August 15, 2025 [6] - Tonix's infectious disease portfolio includes TNX-801 for mpox and smallpox, and TNX-4200, a broad-spectrum antiviral agent with a contract worth up to $34 million with the U.S. Department of Defense [6]

Core Insights - TNX-102 SL is a sublingual formulation of cyclobenzaprine aimed at treating fibromyalgia, with an FDA PDUFA goal date of August 15, 2025, potentially becoming the first new non-opioid analgesic for fibromyalgia in over 15 years [1][7] - The drug has shown statistically significant improvement in reducing fibromyalgia pain in two Phase 3 studies, demonstrating durable activity over 14 weeks [2][3] - TNX-102 SL targets sleep disturbances associated with fibromyalgia and has a favorable tolerability profile, acting as a potent antagonist at four post-synaptic receptors [3][6] Company Overview - Tonix Pharmaceuticals is a biotechnology company focused on developing therapies for pain management and CNS disorders, with TNX-102 SL as a priority product candidate for fibromyalgia [7] - The company has submitted a New Drug Application (NDA) for TNX-102 SL based on positive Phase 3 study results and has received Fast Track designation from the FDA [7] - Tonix also has a diverse development portfolio, including treatments for acute stress reactions, organ transplant rejection, and infectious diseases [7] Industry Context - Fibromyalgia affects over 10 million adults in the U.S., primarily women, and is characterized by chronic pain, non-restorative sleep, and cognitive dysfunction [4] - Current treatment options are often unsatisfactory, leading many patients to rely on chronic opioids, which carry risks of addiction and overdose [2][4] - TNX-102 SL's unique formulation aims to provide a new therapeutic option that addresses both pain and sleep disturbances without the risks associated with opioids [2][6]

Core Insights - Tonix Pharmaceuticals has appointed James "Jim" Hunter to its Board of Directors, effective June 12, 2025, to strengthen its commercial strategy and governance as it prepares for the potential launch of TNX-102 SL for fibromyalgia later this year [1][2][4] Company Overview - Tonix Pharmaceuticals is a fully-integrated biotechnology company focused on transforming therapies for pain management and vaccines for public health challenges, with a development portfolio centered on central nervous system (CNS) disorders [5] - The company is advancing TNX-102 SL, a product candidate for fibromyalgia management, with a New Drug Application (NDA) submitted based on two statistically significant Phase 3 studies, and a PDUFA goal date of August 15, 2025, for marketing authorization [5] Leadership and Experience - Jim Hunter has over 40 years of experience in the biopharmaceutical industry, having held leadership roles at Validus Pharmaceuticals, Relialab, and Novartis, and was instrumental in launching Tonix Medicines and entering the migraine market [1][3] - As Executive Vice President of Commercial Operations at Tonix, Hunter managed all aspects of the company's commercial efforts, including sales, marketing, and market access initiatives [2][4] Product Development and Pipeline - Tonix's immunology development portfolio includes biologics targeting organ transplant rejection, autoimmunity, and cancer, such as TNX-1500, an Fc-modified humanized monoclonal antibody [6] - The infectious disease portfolio features TNX-801, a vaccine for mpox and smallpox, and TNX-4200, a broad-spectrum antiviral agent with a contract worth up to $34 million over five years with the U.S. Department of Defense [6] Commercial Strategy - Tonix Medicines, the commercial subsidiary, markets Zembrace SymTouch and Tosymra for the treatment of acute migraines, and is actively involved in pre-launch activities for TNX-102 SL, including launch strategy and market analysis [2][5][6]

Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully integrated biotechnology company focused on pain management therapies and vaccines for public health challenges [3] - The company has a development portfolio primarily targeting central nervous system (CNS) disorders [3] Key Product Candidates - TNX-102 SL is a product candidate for fibromyalgia management, with an NDA submitted based on two statistically significant Phase 3 studies, and a PDUFA goal date of August 15, 2025 [3] - TNX-102 SL has received Fast Track designation from the FDA for fibromyalgia management [3] - The company is also developing TNX-102 SL for acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina [3] Immunology and Infectious Disease Portfolio - Tonix's immunology portfolio includes TNX-1500, an Fc-modified humanized monoclonal antibody targeting CD40-ligand for preventing allograft rejection and treating autoimmune diseases [3] - The infectious disease portfolio features TNX-801, a vaccine for mpox and smallpox, and TNX-4200, a broad-spectrum antiviral agent with a contract worth up to $34 million over five years with the U.S. Department of Defense [3] Commercial Products - Tonix Medicines, the commercial subsidiary, markets Zembrace SymTouch (sumatriptan injection) and Tosymra (sumatriptan nasal spray) for treating acute migraine in adults [3]

Core Insights - Tonix Pharmaceuticals Holding Corp. is set to present a poster at the Annual European Congress of Rheumatology (EULAR) 2025, focusing on its product candidate TNX-102 SL for fibromyalgia treatment [1][3] Company Overview - Tonix is a fully-integrated biotechnology company with a focus on pain management therapies and vaccines for public health challenges [4] - The company is advancing TNX-102 SL, which has a PDUFA goal date of August 15, 2025, for marketing authorization based on two significant Phase 3 studies [4] - TNX-102 SL has received Fast Track designation from the FDA for fibromyalgia management [4] - The company is also developing TNX-102 SL for acute stress reaction and acute stress disorder under a study funded by the U.S. Department of Defense [4] Product Development - Tonix's immunology portfolio includes TNX-1500, a monoclonal antibody targeting CD40-ligand for preventing organ transplant rejection and treating autoimmune diseases [4] - The infectious disease portfolio features TNX-801, a vaccine for mpox and smallpox, and TNX-4200, a broad-spectrum antiviral agent with a contract worth up to $34 million from the U.S. DoD [4] Marketed Products - Tonix Medicines, the commercial subsidiary, markets Zembrace® SymTouch® and Tosymra® for acute migraine treatment [4]